Circulating Exosomal LncRNAs as Novel Diagnostic Predictors of Severity and Sites of White Matter Hyperintensities / 生物医学与环境科学（英文）

OBJECTIVE@#Exosomal long noncoding RNAs (lncRNAs) are the key to diagnosing and treating various diseases. This study aimed to investigate the diagnostic value of plasma exosomal lncRNAs in white matter hyperintensities (WMH).@*METHODS@#We used high-throughput sequencing to determine the differential expression (DE) profiles of lncRNAs in plasma exosomes from WMH patients and controls. The sequencing results were verified in a validation cohort using qRT-PCR. The diagnostic potential of candidate exosomal lncRNAs was proven by binary logistic analysis and receiver operating characteristic (ROC) curves. The diagnostic value of DE exo-lncRNAs was determined by the area under the curve (AUC). The WMH group was then divided into subgroups according to the Fazekas scale and white matter lesion site, and the correlation of DE exo-lncRNAs in the subgroup was evaluated.@*RESULTS@#In our results, four DE exo-lncRNAs were identified, and ROC curve analysis revealed that exo-lnc_011797 and exo-lnc_004326 exhibited diagnostic efficacy for WMH. Furthermore, WMH subgroup analysis showed exo-lnc_011797 expression was significantly increased in Fazekas 3 patients and was significantly elevated in patients with paraventricular matter hyperintensities.@*CONCLUSION@#Plasma exosomal lncRNAs have potential diagnostic value in WMH. Moreover, exo-lnc_011797 is considered to be a predictor of the severity and location of WMH.

Efficacy and safety for robotic bronchoscope in biopsy of pulmonary nodules: A systematic review and meta-analysis / 中国胸心血管外科临床杂志

@#Objective    To systematically review the clinical utilization of robotic bronchoscopes in diagnosis of pulmonary nodules, including MonarchTM and IonTM platforms, and then evaluate the efficacy and safety of the procedure. Methods    PubMed, EMbase, Web of Science and Cochrane Central Register of Controlled Trials databases were searched by computer for literature about the biopsy of pulmonary nodules with robotic bronchoscope from January 2018 to February 14, 2022. The quality of research was evaluated with Newcastle-Ottawa Scale. RevMan 5.4 software was used to conduct the meta-analysis. Results    Finally, 19 clinical studies with 1 542 patients and 1 697 targeted pulmonary nodules were included, of which 13 studies used the IonTM platform and 6 studies used the MonarchTM platform. The overall diagnostic rate of the two systems was 84.96% (95%CI 62.00%-95.00%), sensitivity for malignancy was 81.79%(95%CI 43.00%-96.00%), the mean maximum diameter of the nodules was 16.22 mm (95%CI 10.98-21.47), the mean procedure time was 61.86 min (95%CI 46.18-77.54) and the rate of complications occurred was 4.76% (95%CI 2.00%-15.00%). There was no statistical difference in the outcomes between the two systems. Conclusion     Robotic bronchoscope provides a high efficacy and safety in biopsy of pulmonary nodules, and has a broad application prospect for pulmonary nodules diagnosis.

Diagnostic Performance of Digital Radiograph and Low-Dose Computed Tomography for the Diagnosis of Fishbone Retention in the Oropharynx

Abstract Introduction Fishbone foreign body retention is one of the most common problem with various clinical manifestations from asymptomatic, abscess formation, and perforation to mediastinitis with subsequence morbidity and mortality. Accurately identifying the location of the fishbone leads to precise removal, which, in turn, prevents serious consequences. Digital radiographs have been widely used for diagnosis, but many studies show poor sensitivity. Object The present study was designed to compare the diagnostic performances of digital radiograph and low-dose computed tomography (CT) for fishbone retention and to demonstrate the radiation dose of the two modalities. Methods We collected 2 pieces of fishbone from each of the 15 species commonly eaten in Southeast Asia. We embedded each fishbone in a fresh pig's neck, then subjected the pig's neck to lateral soft tissue neck digital radiograph. The locations to embed included tonsil, base of tongue, and upper esophagus. Then, we subjected the same specimen to a CT scan. Two experienced radiologists interpreted each image. Results Visibility in the digital radiograph group was 13%, and in CT images group, it was 87% regardless of the locations. The average radiation dose from digital radiographs was 0.4 mGy (radiation dose field), while from CT images it was 8.6 mGy (CT dose index). Conclusion Most of the common fishbones in Southeast Asia could not be visualized by digital radiograph when embedded in the neck. Computed tomography scans demonstrated better diagnostic performance of fishbone retention compared to digital radiographs, regardless of the embedded location.

The clinical value of 18F-FDG PET/CT dual-time-point imaging in diagnosing aortic graft infection / 中华胸心血管外科杂志

Objective:To explore the diagnostic value of 18F-deoxyglucose (FDG) PET/CT dual-time-point imaging (DTPI) in the diagnosis of aortic grafts infection (AGI). Methods:Forty-two patients with suspected AGI were prospectively recruited in this DTPI study from October 2014 to October 2021. There were 35(83%) males and 7 females, mean age (54±15) years old, range 22-79 years old. PET/CT image quality was scored as 5 grading scale. Semi-quantitative analysis of DTPI data was performed using maximum standardized uptake value (SUVmax) of suspected AGI lesions. The percentage of SUVmax change between initial and delayed images were recorded as retention index (RI). Management of Aortic Graft Infection Collaboration (MAGIC) criteria were used as the diagnostic reference criteria for AGI.Results:According to the MAGIC criteria, 27 patients (64%) were positive for AGI, and 15 patients (36%) were negative. The mean RI of AGI was higher than that of non-AGI ones[(26.7±18.9)% vs. (6.4 ±18.8)%, P<0.01]. The sensitivity, specificity, and accuracy of initial SUVmax ≥6 with the presence of AGI was 88.9%, 73.3%, and 83.3%, respectively. Delayed SUVmax ≥6 improved the sensitivity (96.3%) and accuracy (88.1%) for diagnosing AGI. DTPI with 15% increment as the optimal cut-off value of RI improved the specificity (93.3%) and accuracy (90.5%) for diagnosing AGI. Fifteen (56%, 15/27) AGI patients had improved image quality grading on the delayed images, leading to more accurately delineating the detailed extent of the infected aortic graft. Conclusion:18F-FDG PET/CT DTPI has better diagnostic performance for AGI than conventional Single-time-point PET/CT imaging by improving image quality as well as enhancing delineation of infected aortic graft extent.

Ease of use and validity testing of a point-of-care fast test for parasitic vaginosis self-diagnosis

@#There is a demand for patients to self-diagnose their sexually transmitted infections (selftesting), particularly during the coronavirus pandemic to prevent infection spread. We enrolled a cohort of Saudi women in a single-visit prospective study, which was the first of its kind performed in the country. Our aim was to evaluate the OSOM® Trichomonas (OSOM) test, a single-use, point-of-care rapid test, for its efficacy and accessibility as a self-test for Trichomonas vaginalis (Trichomonas) infection. At a public hospital’s gynecology clinic, women received sufficient training on specimen collection and OSOM self-testing. The women’s infection status was re-evaluated using direct wet mount microscopy and clinician performed OSOM using additional swabs. Specimens with discordant results were sorted using an inhouse polymerase chain reaction (PCR). 174 women aged 18 to 35 were registered and selftested at the clinic under the supervision of a gynecologist between June and December 2020, with 84.4 percent (147/174) having a valid result on the first or repeat OSOM. Infection was detected in 12.2% (18/147) of participants, with two-thirds of them symptomatic. Young age, low education, the existence of vaginitis symptoms, and unemployment were identified as key risk factors for infection in the study population, with statistically significant differences seen among women only in terms of education level and employment status (p<0.001). The OSOM self-test performed well (83.3% sensitivity and 98.4% specificity), outperforming the wet mount microscopy (72.2% sensitivity and 100% specificity) and comparable to the clinicians’ OSOM (88.8% sensitivity and 100% specificity). The patients’ and clinicians’ OSOM tests were strongly correlated, with a kappa of 0.89 and a 97.9% agreement. Self-collection of vaginal swabs was accepted and preferred by most women (94%) over the clinician-collection. Overall, our study’s findings may have important consequences for the implementation of Trichomonas screening based on OSOM self-testing approach in the study’s population.

Comparison of two commercial tests (Immy vs. Dynamiker) for cryptococcal capsular antigen

Abstract INTRODUCTION Lateral flow assay is an advanced method useful in the early diagnosis of cryptococcal meningitis. We aimed to compare two commercial tests for cryptococcal capsular antigen in the sera of asymptomatic patients with human immunodeficiency virus in Barranquilla, Colombia. METHODS Thawed (n=162) previously collected serums (2016-2019) were processed using IMMY and Dynamiker cryptococcal antigen lateral flow assay. RESULTS Compared to IMMY's results, Dynamiker's sensitivity, specificity, positive predictive value, negative predictive value, and kappa index were 100%, 89.9%, 48.3%, 100.0%, and 0.61, respectively. CONCLUSIONS The Dynamiker test had excellent sensitivity, acceptable specificity, and a low detection threshold for cryptococcal antigen in the tested samples.

Evaluación del rendimiento diagnóstico de los criterios predictivos de la sociedad británica para el diagnóstico de coledocolitiasis en una población colombiana / Diagnostic performance of the British Society of Gastroenterology predictive criteria for the diagnosis of choledocholithiasis in a Colombian population

Resumen Introducción: la coledocolitiasis (CLDL) puede ser difícil de diagnosticar. Su importancia radica en sus potenciales complicaciones y en que el tratamiento se realiza mediante colangiopancreatografía retrógrada endoscópica (CPRE), un procedimiento con riesgo de generar complicaciones. Se han propuesto guías para su diagnóstico y la más empleada es la de la ASGE (American Society for Gastrointestinal Endoscopy), cuyo rendimiento no es ideal. Recientemente, se ha publicado la guía británica. Este estudio se realizó para establecer el rendimiento de ambas guías. Materiales y métodos: estudio prospectivo realizado entre agosto 1 de 2017 y julio 31 de 2018. Resultados: se incluyeron 300 pacientes para el análisis. Se realizó una CPRE en 145 pacientes y se confirmó la existencia de CLDL en 124 de ellos (85,5 %). La mediana de aspartato aminotransferasa (AST) y alanina aminotransferasa (ALT) fue mayor en los que tuvieron CLDC (207 mg/dL y 290 mg/dl, respectivamente). Entre tanto, la tasa de complicaciones posteriores a la CPRE fue del 5,5 %. El análisis multivariado no encontró una asociación significativa para alguna variable predictora de CLDL. En pacientes con alta probabilidad, las guías británicas tuvieron una sensibilidad del 65 % y una especificidad del 33 %, mientras que las guías ASGE mostraron una sensibilidad del 74 % y una especificidad del 28 %. En probabilidad intermedia fueron menos eficientes. Conclusiones: los criterios de la ASGE y la BSG (British Society of Gastroenterology) no tienen un buen desempeño en la población estudiada, a fin de discriminar la existencia o no de CLDL. La guía de la ASGE mostró un mejor rendimiento en general que las guías británicas.

Abstract Introduction: Choledocholithiasis (CDL) may be difficult to diagnose. The relevance of making a timely diagnosis lies in its potential negative effects and the fact that treatment requires performing endoscopic retrograde cholangiopancreatography (ERCP), which is a procedure with a high risk of complications. Several guidelines have been proposed for its diagnosis, including the ASGE Guidelines, which are the most widely used although they do not have an ideal performance, and the guidelines recently published by the BSG. The objective of this study was to compare the performance of both guidelines. Materials and methods: Prospective study carried out between August 1, 2017, and July 31, 2018. Results: 300 patients were included for analysis. 145 underwent ERCP and choledocholithiasis was confirmed in 124 of them (85.5%). Median AST and ALT levels were higher in patients with choledocholithiasis (207 mg/dL and 290 mg/dL). The rate of post-ERCP complications was 5.5%. Multivariate analysis found no significant association for any predictor of CDL. Regarding the "high probability" score, the BSG guidelines had sensitivity of 65% and specificity of 33%, while the ASGE guidelines had sensitivity of 74% and specificity of 28%. Both guidelines were less efficient for "intermediate probability". Conclusions: The ASGE and BSG criteria do not perform well in the population studied to determine whether they had CDL. The ASGE guidelines had a better overall performance than the BSG guidelines.

Automated Breast Ultrasound System for Breast Cancer Evaluation: Diagnostic Performance of the Two-View Scan Technique in Women with Small Breasts

0.05).CONCLUSION: 2-VST of ABUS achieved comparable scan coverage and diagnostic performance to that of conventional 3-VST in women with small breasts.

Establishment of a recombinase-aided isothermal amplification assay for nucleic acid detection of Echinococcus multilocularis and its preliminary application / 中国血吸虫病防治杂志

Objective To establish a rapid nucleic acid detection technique for identification of Echinococcus multilocularis based on the recombinase aided isothermal amplification assay (RAA) and assess its diagnostic efficiency. Methods The mitochondrial gene sequence of E. multilocularis (GenBank accession number: AB018440) was used as a target sequence. The primers were designed according to the RAA reaction principle and synthesized, and RAA was performed using the generated primers. E. multilocularis genomic DNA at various concentrations and the pMD19-T (Simple) vector containing various copies of the target gene fragment were amplified using RAA to evaluate its sensitivity for detection of E. multilocularis, and RAA was em- ployed to detect the genomic DNA of E. granulosus G1 genotype, Taenia saginata, T. asiatica, T. multiceps, Dipylidium caninum, Toxocara canis, Trichuris trichiura, Giardia lamblia, Fasciola hepatica, Paragonimus westermani, Fasciola gigantica and Clonorchis sinensis to evaluate its specificity. In addition, the optimized RAA was employed to detect nine tissue specimens of E. granulosus-infected animals, 3 fecal samples from E. granulosus-infected dogs and 2 fecal samples from field infected dogs to examine its reliability and feasibility. Results The established RAA was able to detect the specific target gene fragment of E. multilocularis within 40 min. The lowest detect limit of RAA was 10 pg if E. multilocularis genomic DNA served as a template. If the re- combinant plasmid was used as a template, the minimally detectable copy number of RAA was 104. In addition, RAA was nega- tive for the genomic DNA of E. granulosus G1 genotype, T. saginata, T. asiatica, T. multiceps, D. caninum, T. canis, T. trichiura, G. lamblia, F. hepatica, P. westermani, F. gigantica and C. sinensis. The established RAA was positive for detection of the tissue specimens of infected animals, and simulated and field dog stool samples. Conclusion A rapid, sensitive and specific RAA is established, which shows promising values in identification of E. multilocularis and gene diagnosis of alveolar echinococcosis.

Establishment of a nucleic acid assay for detection of Echinococcus granulosus based on recombinase-aided isothermal amplification assay / 中国血吸虫病防治杂志

Objective To establish a nucleic acid assay for detection of Echinococcus granulosus based on recombinase-aided isothermal amplification (RAA) assay. Methods The 12S rRNA gene of E. granulosus was selected as the target gene, and the specific primers and fluorescent probes for RAA assay were designed, screened and synthesized to establish a fluorescent RAA assay for detection of E. granulosus. The sensitivity of the fluorescent RAA assay was evaluated using different copy numbers of target gene sequence-contained recombinant plasmids and various concentrations of E. granulosus genomic DNA as templates, and the specificity of the fluorescent RAA assay was evaluated using the genomic DNA from E. granulosus, E. multilocularis, Schistosoma japonicum, S. mansoni, Ancylostoma duodenale, Clonorchis sinensis, Taenia saginata, Spirometra mansoni and Taenia solium as templates. Results A fluorescent RAA assay was successfully established for detection of E. granulosus, which achieved specific amplification of E. granulosus genomic DNA within 20 min at 39 ℃. The lowest detection limit of the fluorescent RAA assay was 10 copies/μL of recombinant plasmids and 0.1 ng/μL E. granulosus genomic DNA, which exhibited a high sensitivity, and the fluorescent RAA assay was all negative for the genomic DNA from E. multilocularis, S. japonicum, S. mansoni, A. duodenale, C. sinensis, T. saginata, Spirometra mansoni and T. solium, which exhibited a high specificity. In addition, this fluorescent RAA assay successfully detected genomic DNA from E. granulosus cysts. Conclusions A rapid, sensitive and specific fluorescent RAA assay is successfully established for nucleic acid detection of E. granulosus.

Procalcitonin as an Early Laboratory Marker of Sepsis in Neonates: Variation in Diagnostic Performance and Discrimination Value

@#Background: As an early recognition of neonatal sepsis is important for triggering the initiation of treatment, this study was thus designed to assess the diagnostic performance and discrimination value of procalcitonin (PCT) in neonatal sepsis cases. Methods: This cross-sectional study, which was carried out at the Paediatric Intensive Care Unit of Hospital Universiti Sains Malaysia (HUSM) in Kelantan, Malaysia, had involved 60 neonates admitted for suspected sepsis. Sensitivity, specificity, positive predictive values (PPV), negative predictive values (NPV) and the area under receiver operating characteristics curve (AUC) for PCT were determined at initial presentation (0 h) as well as 12 h and 24 h after presentation in comparison to blood culture as the gold standard. Results: The study consisted of 27 (45.0%) male and 33 (55.0%) female neonates with a mean (SD) age of 76.8 (48.25) h. At cut-off PCT value of > 2 ng/mL, the sensitivity, specificity, PPV and NPV were 66.7%, 66.7%, 33.3% and 88.9% at 0 h. The respective parameters were 83.3%. 56.3%, 32.3% and 93.1% at 12 h and 83.3%, 52.1%, 30.3% and 92.6% at 24 h. AUC was 71.6%, 76.6% and 71.7% at 0 h, 12 h and 24 h. Conclusions: Diagnostic performance and discrimination values of PCT for diagnosis of neonatal sepsis varied with time of obtaining the blood samples. The PCT result at 12 h demonstrates the most optimal diagnostic performance and discrimination values.

Clinical Utility of a Fully Automated Microsatellite Instability Test with Minimal Hands-on Time

BACKGROUND: Microsatellite instability (MSI) analysis is becoming increasingly important in many types of tumor including colorectal cancer (CRC). The commonly used MSI tests are either time-consuming or labor-intensive. A fully automated MSI test, the Idylla MSI assay, has recently been introduced. However, its diagnostic performance has not been extensively validated in clinical CRC samples.METHODS: We evaluated 133 samples whose MSI status had been rigorously validated by standard polymerase chain reaction (PCR), clinical next-generation sequencing (NGS) cancer panel test, or both. We evaluated the diagnostic performance of the Idylla MSI assay in terms of sensitivity, specificity, and positive and negative predictive values, as well as various sample requirements, such as minimum tumor purity and the quality of paraffin blocks.RESULTS: Compared with the gold standard results confirmed through both PCR MSI test and NGS, the Idylla MSI assay showed 99.05% accuracy (104/105), 100% sensitivity (11/11), 98.94% specificity (93/94), 91.67% positive predictive value (11/12), and 100% negative predictive value (93/93). In addition, the Idylla MSI assay did not require macro-dissection in most samples and reliably detected MSI-high in samples with approximately 10% tumor purity. The total turnaround time was about 150 minutes and the hands-on time was less than 2 minutes.CONCLUSIONS: The Idylla MSI assay shows good diagnostic performance that is sufficient for its implementation in the clinic to determine the MSI status of at least the CRC samples. In addition, the fully automated procedure requires only a few slices of formalin-fixed paraffin-embedded tissue and might greatly save time and labor.

Effect of a Deep Learning Framework-Based Computer-Aided Diagnosis System on the Diagnostic Performance of Radiologists in Differentiating between Malignant and Benign Masses on Breast Ultrasonography

OBJECTIVE: To investigate whether a computer-aided diagnosis (CAD) system based on a deep learning framework (deep learning-based CAD) improves the diagnostic performance of radiologists in differentiating between malignant and benign masses on breast ultrasound (US). MATERIALS AND METHODS: B-mode US images were prospectively obtained for 253 breast masses (173 benign, 80 malignant) in 226 consecutive patients. Breast mass US findings were retrospectively analyzed by deep learning-based CAD and four radiologists. In predicting malignancy, the CAD results were dichotomized (possibly benign vs. possibly malignant). The radiologists independently assessed Breast Imaging Reporting and Data System final assessments for two datasets (US images alone or with CAD). For each dataset, the radiologists' final assessments were classified as positive (category 4a or higher) and negative (category 3 or lower). The diagnostic performances of the radiologists for the two datasets (US alone vs. US with CAD) were compared. RESULTS: When the CAD results were added to the US images, the radiologists showed significant improvement in specificity (range of all radiologists for US alone vs. US with CAD: 72.8–92.5% vs. 82.1–93.1%; p < 0.001), accuracy (77.9–88.9% vs. 86.2–90.9%; p = 0.038), and positive predictive value (PPV) (60.2–83.3% vs. 70.4–85.2%; p = 0.001). However, there were no significant changes in sensitivity (81.3–88.8% vs. 86.3–95.0%; p = 0.120) and negative predictive value (91.4–93.5% vs. 92.9–97.3%; p = 0.259). CONCLUSION: Deep learning-based CAD could improve radiologists' diagnostic performance by increasing their specificity, accuracy, and PPV in differentiating between malignant and benign masses on breast US.

Hepatic Artery Occlusion after Liver Transplantation in Patients with Doppler Ultrasound Abnormality: Increasing Sensitivity of Contrast-Enhanced Ultrasound Diagnosis

OBJECTIVE: To investigate whether diagnostic performance of contrast-enhanced ultrasound (CEUS) could be improved with modified criteria to diagnose significant hepatic artery occlusion (HAO) and to determine the role of CEUS in patients with a tardus-parvus hepatic artery (HA) pattern on Doppler US. MATERIALS AND METHODS: Among 2679 adult liver transplantations performed over 7 years, HAO was suspected in 288 recipients, based on Doppler ultrasound. Among them, 130 patients underwent CEUS. After excluding two technical failures, 128 CEUS images were retrospectively reviewed to search for abnormal findings, such as no HA enhancement, abnormal HA enhancement (delayed, faint, and discontinuous enhancement), and perfusion defect in the liver parenchyma. The performance CEUS abnormalities were assessed in the patients overall and in subgroups based on Doppler ultrasound abnormality (group A, no flow; group B, tardus-parvus pattern) and were compared based on the area under the receiver operating characteristic curve (AUC). RESULTS: HAO were diagnosed in 41 patients by surgery, angiography, or follow-up abnormality. By using the conventional criterion (no HA enhancement) to diagnose HAO in patients overall, the sensitivity, specificity, and AUC were 58.5%, 100%, and 0.793, respectively. Modified criteria for HAO (no HA enhancement, abnormal enhancement, or parenchymal perfusion defect) showed statistically significantly increased sensitivity (97.6%, 40/41) and AUC (0.959) (p < 0.001), although the specificity (95.4%, 83/87) was slightly decreased. The sensitivity and specificity of the modified criteria in Groups A and B were 97.1% (33/34) and 95.7% (22/23), and 100% (7/7) and 95.3% (61/64), respectively. CONCLUSION: Modified criteria could improve diagnostic performance of CEUS for HAO, particularly by increasing sensitivity. CEUS could be useful for diagnosing HAO even in patients with a tardus-parvus HA pattern on Doppler US, using modified criteria.

Prognostic use of Prostate Specific Antigen, Some Renal Indices and Uric Acid in the Diagnosis of Prostate Cancer and Renal Impairment at Urology Clinic Federal Medical Centre Lokoja, Nigeria

Aims: Improved diagnosis of prostate cancer has led to increasing life expectancy in adult men. The use of PSA as the current practice for screening and treatment has become a key prognostic factor in the management of PCa. This study was designed to evaluate the prognostic use of serum PSA, creatinine, urea, protein and uric acid in PCa subjects with or without renal impairment. Study Design: The study was a prospective study conducted between March and September 2016 at federal Medical Centre Lokoja, Kogi State, Nigeria. Methods: One hundred and ten adult men aged 51 - 70 years were conveniently recruited for the study. Diagnosis was based on biopsy, PSA, Cr/U and UA results obtained, and grouped as (A) PCa subjects with RI (35), (B) PCa subjects without RI (35) and 40 apparently healthy men (Controls) which is regarded as group (C). Blood samples were collected and analyzed for PSA and renal indices using ELISA and colorimetric methods respectively. Results: The result showed that serum tPSA, fPSA, cPSA, %fPSA, creatinine, urea and uric acid were significantly higher while total protein was significantly lower in PCa subjects with RI compared with controls (P<.05). Similar results were obtained in PCa without RI compared with controls except for urea (P=.001respectively). However, tPSA, fPSA, cPSA were significantly lower while creatinine, urea and uric acid were significantly higher in Pca with RI compared with the corresponding values in PCa without RI (P<.05). The correlation between cPSA, creatinine and urea showed association between PCa and RI. ROC showed that tPSA and cPSA had significantly higher diagnostic performance than fPSA and % fPSA in the prediction of PCa associated with RI while Creatinine, urea and uric acid had significantly higher diagnostic accuracy in the prediction of RI associated with PCa within the age range of 50-61 than 61-70 years. Conclusions: Increased serum uric acid level observed in RI subjects suggests decreased excretion of uric acid by the kidney. ROC analysis shows significant evidence that tPSA and cPSA have higher predictive value for PCa with or without RI while creatinine, urea and uric acid have higher predictive efficacy for RI in PCa subjects. Adult men from 50 years are recommended for early screening for PDs to minimize progression to RI.

Diagnostic Performance of Shear Wave Elastography as Add-on Test in Thyroid Nodules: a Systematic Review and Meta-Analysis

BACKGROUND AND OBJECTIVES: The diagnostic performance of shear wave elastography (SWE) combined with ultrasound (US) in the differential diagnosis of thyroid nodules was evaluated. MATERIALS AND METHODS: 459 articles were collected using KoreaMed, Ovid-MEDLINE, Ovid-EMBASE, and Cochrane Library. The searching words were ‘{(elastography and shear).mp. OR SWE.mp. OR acoustic radiation force impulse.mp. OR ARFI.mp. OR acuson.mp. OR aixplorer.mp.}’. Two authors independently performed article selection and evaluation of the quality of studies with Scottish Intercollegiate Guidelines Network tool. RESULTS: 2582 specimens (thyroid nodules) from 11 studies selected were included in this review. Combined use of US and SWE was reported higher specificity in five literatures, lower specificity in five studies, and no changes in 1 study when compared to US. We performed meta-analysis using data from 10 studies. The pooled sensitivity and specificity of US and SWE group for the differential diagnosis of benign and malignant nodules were 0.91 (I2=83.4%), 0.73 (I2=95.9%). The pooled sensitivity and specificity of US alone group were 0.88 (I2=93.2%), 0.71 (I2=92.7%). CONCLUSION: SWE is not effective in the differential diagnosis of thyroid nodules to minimize unnecessary biopsy of nodules. The included studies showed significant heterogeneity of results.

Comparative Assessment of Diagnostic Performances of Two Commercial Rapid Diagnostic Test Kits for Detection of Plasmodium spp. in Ugandan Patients with Malaria

Prompt diagnosis of malaria cases with rapid diagnostic tests (RDTs) has been widely adopted as an effective malaria diagnostic tool in many malaria endemic countries, primarily due to their easy operation, fast result output, and straightforward interpretation. However, there has been controversy about the diagnostic accuracy of RDTs. This study was conducted to evaluate the diagnostic performances of the 2 commercially available malaria RDT kits, RapiGEN Malaria Ag Pf/Pv (pLDH/pLDH) and Asan EasyTestTM Malaria Ag Pf/Pv (HRP-2/pLDH) for their abilities to detect Plasmodium species in blood samples collected from Ugandan patients with malaria. To evaluate the diagnostic performances of these 2 RDT kits, 229 blood samples were tested for malaria infection by microscopic examination and a species-specific nested polymerase chain reaction. The detection sensitivities for P. falciparum of Malaria Ag Pf/Pv (pLDH/pLDH) and Asan EasyTestTM Malaria Ag Pf/Pv (HRP-2/pLDH) were 87.83% and 89.57%, respectively. The specificities of the 2 RDTs were 100% for P. falciparum and mixed P. falciparum/P. vivax infections. These results suggest that the 2 RDT kits showed reasonable levels of diagnostic performances for detection of the malaria parasites from Ugandan patients. However, neither kit could effectively detect P. falciparum infections with low parasitaemia ( < 500 parasites/μl).

Development of a Rapid Automated Fluorescent Lateral Flow Immunoassay to Detect Hepatitis B Surface Antigen (HBsAg), Antibody to HBsAg, and Antibody to Hepatitis C

BACKGROUND: Accurate, rapid, and cost-effective screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV) infection may be useful in laboratories that cannot afford automated chemiluminescent immunoassays (CLIAs). We evaluated the diagnostic performance of a novel rapid automated fluorescent lateral flow immunoassay (LFIA). METHODS: A fluorescent LFIA using a small bench-top fluorescence reader, Automated Fluorescent Immunoassay System (AFIAS; Boditech Med Inc., Chuncheon, Korea), was developed for qualitative detection of hepatitis B surface antigen (HBsAg), antibody to HBsAg (anti-HBs), and antibody to HCV (anti-HCV) within 20 minutes. We compared the diagnostic performance of AFIAS with that of automated CLIAs—Elecsys (Roche Diagnostics GmbH, Penzberg, Germany) and ARCHITECT (Abbott Laboratories, Abbott Park, IL, USA)—using 20 seroconversion panels and 3,500 clinical serum samples. RESULTS: Evaluation with the seroconversion panels demonstrated that AFIAS had adequate sensitivity for HBsAg and anti-HCV detection. From the clinical samples, AFIAS sensitivity and specificity were 99.8% and 99.3% for the HBsAg test, 100.0% and 100.0% for the anti-HBs test, and 98.8% and 99.1% for the anti-HCV test, respectively. Its agreement rates with the Elecsys HBsAg, anti-HBs, and anti-HCV detection assays were 99.4%, 100.0%, and 99.0%, respectively. AFIAS detected all samples with HBsAg genotypes A-F and H and anti-HCV genotypes 1, 1a, 1b, 2a, 2b, 4, and 6. Cross-reactivity with other infections was not observed. CONCLUSIONS: The AFIAS HBsAg, anti-HBs, and anti-HCV tests demonstrated diagnostic performance equivalent to current automated CLIAs. AFIAS could be used for a large-scale HBV or HCV screening in low-resource laboratories or low-to middle-income areas.

Complementary Role of Elastography Using Carotid Artery Pulsation in the Ultrasonographic Assessment of Thyroid Nodules: A Prospective Study

OBJECTIVE: The aim of this study was to evaluate the diagnostic performance of gray-scale ultrasonography (US), Doppler scan, and elastography using carotid artery pulsation in the diagnosis of thyroid nodules and to find a complementary role of elastography. MATERIALS AND METHODS: A total 197 thyroid nodules with 91 malignant and 106 benign pathologic results from 187 patients (41 males and 146 females; age range, 20–83 years; mean age, 49.4 years) were included in this prospective study. The gray-scale, Doppler US images, elastography with elasticity contrast index (ECI), and stiffness color were assessed. The diagnostic performances of each dataset were assessed in order to differentiate benign from malignant thyroid nodules. RESULTS: The optimal cut-off value of the ECI was 1.71. The area under receiver operating characteristic curve (Az value) was 0.821 for gray-scale US, 0.661 for the ECI, 0.592 for stiffness color, and 0.539 for Doppler US. The Az value for a combined assessment of gray-scale US and the ECI was higher than that for the gray-scale US alone; however, there was no statistical difference between the two (p = 0.219). The median ECI values of follicular thyroid carcinoma (FTC) and follicular variant of papillary thyroid carcinoma (FVPTC) were significantly lower than those of the other malignant lesions (p = 0.005). Meanwhile, the diffuse sclerosing variant of PTC and a metastatic nodule showed the two highest median values of the ECI. CONCLUSION: For differentiating thyroid nodules, the diagnostic performances of the combination of gray-scale US and elastography with the ECI were similar to, but not superior, to those of gray-scale US alone. FVPTC and FTC have a significantly lower ECI value than those of the other malignant lesions.

Diagnostic Performance and Comparative Evaluation of the Architect, Liaison, and Platelia Epstein-Barr Virus Antibody Assays

BACKGROUND: Epstein-Barr Virus (EBV) is one of the most prevalent causes of viral infection in humans. EBV infection stage (acute, past, or absent infection) is typically determined using a combination of assays that detect EBV-specific markers, such as IgG and IgM antibodies against the EBV viral capsid antigen (VCA) and IgG antibodies against the EBV nuclear antigen (EBNA). We compared the diagnostic performance and agreement of results between three commercial EBV antibody assays using an EBV performance panel (SeraCare Life Science, Milford, MA, USA) as a reference. METHODS: EBV antibody tests of EBV VCA IgM, VCA IgG, and EBNA IgG antibodies were performed by the Architect (Abbott Diagnostics, Wiesbaden, Germany), Liaison (DiaSorin, Saluggia, Italy), and Platelia (Bio-Rad, Marnes-la-Coquette, France) assays. Agreement between the three assays was evaluated using 279 clinical samples, and EBV DNA and antibody test results were compared. RESULTS: The three EBV antibody assays showed good diagnostic performance with good and excellent agreement with the performance panel (kappa coefficient, >0.6). The overall VCA IgM positivity rate was higher in EBV DNA-positive samples than in EBV DNA-negative samples for all three EBV antibody assays (P=0.02). The three EBV antibody assays exhibited good agreement in results for the clinical samples. CONCLUSIONS: The diagnostic performance of the three EBV antibody assays was acceptable, and they showed comparable agreement in results for the clinical samples.